HypercholesterolemiaOLALIPNCT05594979
Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
A study testing TOTUM-070 in people with Hypercholesterolemia and Cardiovascular Risk Factor, run by Valbiotis at 1 site in France.
Trial summary
This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Risk Factor, Dyslipidemias
- What is being tested?
- TOTUM-070
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2022to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- Body mass index (BMI) between 18.5 and 35 kg/m²
- Moderate hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment according to the current recommendations (European Society of Cardiology /European Atherosclerosis Society, 2019)
- Fasting blood LDL cholesterol level (using Friedewald estimation method) between 1.3 and 1.9 g/L
- Fasting blood triglycerides level ≤ 2.2 g/L
Main Exclusion Criteria:
- Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations
- Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
- With a history of ischemic cardiovascular event
- Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease)
- Fasting glucose plasma concentration > 1.26 g/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Center, Single Arm, Clinical Trial to Assess the Consumption Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.
- Conditions
- Hypercholesterolemia, Cardiovascular Risk Factor, Dyslipidemias, Atherosclerosis, Cardio-metabolic Risk
- Being tested
- TOTUM-070
- Keywords
- Moderate hypercholesterolemia, Nutrition healthcare, Plant extracts
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOTUM-070Dietary supplement
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes
| Study group | Role | What they receive |
|---|---|---|
| TOTUM-070 | Experimental | Experimental active diet supplement TOTUM-070 taken 2 times per day Receives: Dietary Supplement: TOTUM-070 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of blood LDL cholesterol concentration at 6 weeks
LDL cholesterol (Friedewald method)
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Secondary outcomes (7)
Change from baseline of the fasting blood concentration of triglycerides
Triglycerides
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of total cholesterol
Total cholesterol
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of HDL cholesterol
HDL cholesterol
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of non-HDL cholesterol
Non-HDL cholesterol
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of free fatty acids
Free fatty acids
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of apolipoprotein-A1
Apolipoprotein-A1
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of apolipoprotein-B
Apolipoprotein-B
Measured: V1 (baseline) and V2 (6 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start14 Dec 2022
- Primary completion6 Sep 2023
- Study completion27 Sep 2023
Why it stopped: The recruitment period has come to an end and will not be renewed due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valbiotis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594979
- Sponsor's protocol ID
- VCT-015
- Other IDs
- 2022-A01474-39
- Acronym
- OLALIP
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Center, Single Arm, Clinical Trial to Assess the Consumption Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
- ClinicalTrials.gov ID
- NCT05594979
- Acronym / sponsor ID
- OLALIP / VCT-015
- Conditions
- Hypercholesterolemia, Cardiovascular Risk Factor, Dyslipidemias, Atherosclerosis, Cardio-metabolic Risk
- Keywords
- Moderate hypercholesterolemia, Nutrition healthcare, Plant extracts
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment period has come to an end and will not be renewed due to insufficient recruitment.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ValbiotisIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Clermont-Ferrand
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOTUM-070 | Experimental | Dietary Supplement: TOTUM-070Experimental active diet supplement TOTUM-070 taken 2 times per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOTUM-0702.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes | Dietary supplement | TOTUM-070 |
Primary outcome
Change from baseline of blood LDL cholesterol concentration at 6 weeks
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
LDL cholesterol (Friedewald method)
7 secondary outcomes
Change from baseline of the fasting blood concentration of triglycerides
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of total cholesterol
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of HDL cholesterol
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of non-HDL cholesterol
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of free fatty acids
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of apolipoprotein-A1
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Change from baseline of the fasting blood concentration of apolipoprotein-B
Time frame: V1 (baseline) and V2 (6 weeks of intervention)
Results and safety
The study was stopped early (reason given: The recruitment period has come to an end and will not be renewed due to insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOTUM-070 in people with Hypercholesterolemia and Cardiovascular Risk Factor, run by Valbiotis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The recruitment period has come to an end and will not be renewed due to insufficient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of blood LDL cholesterol concentration at 6 weeks (time frame: V1 (baseline) and V2 (6 weeks of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.